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Protocol Details

A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational anti-Influenza Immune Plasma for the Treatment of Influenza

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-I-0043

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 0
Max Age: 99

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Antiviral;
H1N1 Plasma;
Infectious Disease;
S-OIV;
Swine Flu

Recruitment Keyword(s)

Swine Flu;
H1N1

Condition(s)

H1N1 Influenza;
Swine Flu

Investigational Drug(s)

Anti-H1N1 Influenza A Immune Plasma

Investigational Device(s)

None

Intervention(s)

Drug: H1N1 Plasma
:

Supporting Site

National Institute of Allergy and Infectious Diseases

Background:

- Influenza A/H1N1 2009 (commonly referred to as swine flu) is a novel influenza virus. Because of the high rates of infection and death in spite of treatment with current antivirials and the limited therapeutic options for influenza, additional treatments for H1N1 are warranted.

- One potential treatment is the use of hyper-immune plasma as immunotherapy. This plasma is collected from individuals who have high levels of antibodies in the bloodstream, because they either have had the disease or have been vaccinated against it. Researchers are interested in determining whether infusions of hyper-immune plasma are a safe and effective treatment for the H1N1 influenza.

Objectives:

- To assess the safety, effectiveness, and lab results of H1N1 plasma in subjects with H1N1 influenza.

Eligibility:

- Individuals of any age who have been hospitalized with influenza A/H1N1 2009 and are at risk for severe disease. This study may include children and pregnant women.

Design:

- Participants will provide brief medical history and have a physical examination, including blood samples to check H1N1 levels. Researchers will swab the nose and the back of the mouth to test for influenza.

- All participants will receive treatment for influenza with standard anti-influenza medications.

- Participants will receive either plasma containing high levels of antibody against the influenza virus in addition to standard of care, or standard of care alone. Individuals who receive plasma will have two doses, separated by a few hours.

- Participants will be evaluated 2, 4, 7, 14, and 28 days after receiving the study treatment. Those who are no longer in the hospital will need to return to the clinic for these visits. Researchers will perform a brief exam, ask questions about symptoms, and collect blood and nose/mouth swab samples as needed.

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Eligibility

INCLUSION CRITERIA:

ENROLLMENT (SCREENING):

Subjects must meet all of the following criteria to be enrolled for randomization into the study:

1. Provide written informed consent before initiation of any study procedures.

2. Hospitalization for signs and symptoms of influenza (decision for hospitalization will be up to the individual treating clinician).

3. Study plasma available.

RANDOMIZATION:

Subjects must meet all of the following criteria to be randomized in the study:

1. Provide written informed consent before initiation of any study procedures.

2. Diagnosis of influenza A or B within 48 hours prior to enrollment by the local assay including rapid antigen, direct fluorescent antibody (DFA), polymerase chain reaction (PCR), or culture, and must be able to detect and distinguish influenza A from influenza B.

3. Hospitalization for signs and symptoms of influenza (decision for hospitalization will be up to the individual treating clinician).

4. Abnormal respiratory status defined as room air saturation of oxygen (SaO2) , less than 93% OR tachypnea documented at any point within 24 hours prior to randomization.

5. Agree to the storage of specimens and data.

6. ABO compatible study plasma with activity against locally circulating strains of influenza is available.

EXCLUSION CRITERIA:

RANDOMIZATION:

Subjects who meet any of the following criteria will be excluded from study participation:

1. Receipt of non-licensed treatment for influenza within the last 2 weeks (or plans to receive anytime during the study). Use, however, of licensed drugs at non-approved doses or for off-label indications, or use of drugs under an Emergency Use Authorization (EUA) is not exclusionary.

2. History of severe allergic reaction to blood products (as judged by the investigator).

3. Medical conditions for which receipt of 500mL volume (or 8 mL/kg for pediatric patients) may be dangerous to the subject (e.g. decompensated congestive heart failure, congenital heart disease for children, etc).

4. Clinical suspicion that the etiology of acute illness (acute decompensation) is primarily due to a condition other than active influenza virus replication (e.g., a bacterial or fungal infection).


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Citations:

Morse SS. Factors in the emergence of infectious diseases. Emerg Infect Dis. 1995 Jan-Mar; 1(1):7-15.

Bean WJ, Schell M, Katz J, Kawaoka Y, Naeve C, Gorman O, Webster RG. Evolution of the H3 influenza virus hemagglutinin from human and nonhuman hosts. J Virol. 1992 Feb;66(2):1129-38.

de Jong MD, Tran TT, Truong HK, Vo MH, Smith GJ, Nguyen VC, Bach VC, Phan TQ, Do QH, Guan Y, Peiris JS, Tran TH, Farrar J. Oseltamivir resistance during treatment of influenza A (H5N1) infection. N Engl J Med. 2005 Dec 22; 353(25):2667-72.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Richard T. Davey Jr., M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
BG 10-CRC RM 4-1479
10 CENTER DR
BETHESDA MD 20814
(301) 496-8029
rdavey@niaid.nih.gov

Jocelyn Voell, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 8C406
10 Center Drive
Bethesda, Maryland 20892
(301) 435-7913
jvoell@niaid.nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01052480

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